UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019338 |
|---|---|
| Receipt number | R000022363 |
| Scientific Title | Clinical outcome of risedronate therapy for patients with Paget's disease of bone |
| Date of disclosure of the study information | 2015/10/15 |
| Last modified on | 2021/10/18 14:01:58 |
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Basic information
Public title
Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Acronym
Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Scientific Title
Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Scientific Title:Acronym
Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Region
| Japan |
Condition
Condition
Paget's disease of bone
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of high dose resedronate for patients with Paget's disease of bone
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALP value
Key secondary outcomes
pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
risedronate 17.5mg
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ALP value over normal range
Key exclusion criteria
not tolerated for risedronate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Nishida |
Organization
Nagoya University Hospital
Division name
Orthopaedic Surgery
Zip code
4668550
Address
65-Tsurumai, Showa, Nagoya
TEL
052-741-2111
ynishida@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Nishida |
| Middle name | |
| Last name | Yoshihiro |
Organization
Nagoya University Hospital
Division name
Orthopaedic Surgery
Zip code
466-8550
Address
65-Tsurumai, Showa, Nagoya
TEL
052-741-2111
Homepage URL
ynishida@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPA:Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
Orthopaedic surgery, 65-Tsurumai
Tel
0527412111
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Watching the progress of the case
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Analysis completed
Management information
Registered date
| 2015 | Year | 10 | Month | 14 | Day |
Last modified on
| 2021 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022363
